Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms

Not Applicable

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: Probiotic

• Registration Number: NCT01653652
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

The purpose of the current study is to evaluate the efficacy of administering a probiotic in adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.

Detailed Description

Adult subjects with documented seasonal allergic rhinitis (SAR) to grass pollen will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks during the grass pollen allergy season. Total nasal symptom score (TNSS) will be compared over 8 weeks between the two treatment groups.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-07
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-07-31
• Study Completion: 2012-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Adults aged 18 to 65 years of age at the time of enrolment.
• Established seasonal allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis >2 years)
• Positive Skin Prick Test (SPT)to Grass Pollen (GP).
• Presence of specific IgE to Grass Pollen (GP)
• Have a Body Mass Index in the range 19-32 kg/m2
• Have signed the consent form
• Have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period

Exclusion Criteria

• Subjects currently under treatment with antibiotics or undergoing allergen immunotherapy at the time of enrolment
• Pregnancy
• Vasomotor rhinitis, nasal cavity disorders (nasal polyps), ear infections otitis media).
• Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)
• Subjects diagnosed with asthma
• Subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months
• Subjects on chronic use of systemic corticosteroids prior to randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Maltodextrin	maltodextrin powder to be taken daily
Probiotic	Probiotic	Probiotic blended in maltodextrin powder to be taken daily

Primary Outcome Measures

Name	Time	Method
Total nasal symptom score (TNSS)	every day over 8 weeks	Total nasal symptom score (TNSS) measuring nasal congestion, runny nose, nasal itching and sneezing on a scale of 0-12 will be compared over 8 weeks between the two treatment groups.

Secondary Outcome Measures

Name	Time	Method
Well being index	every week over 8 weeks
Specific IgE	Baseline and end of study
miniRQLQ	every week for 8 weeks	Validated rhinoconjunctivitis quality of life questionnaire (mini RQLQ) measured weekly
Total ocular symptom score (TOSS)	every day over 8 weeks
Individual nasal and ocular symptoms scores	every day over 8 weeks
Medication Score	every week over 8 weeks

Trial Locations

Locations (1)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany